Richard Pazdur, MD, and Jennifer J. Gao, MD, of the Oncology Center of Excellence (OCE) at the US Food and Drug Administration (FDA) recently published an update on the different initiatives that the OCE has either newly undertaken or continued to optimize cancer care since the start of the coronavirus disease 2019 (COVID-19) pandemic.1
In addition to issuing the Conduct of Clinical Trials of Medical Products during the COVID-19 Public Health Emergency guidance, which specifically addresses how to ensure the safety of trial participants while maintaining trial integrity, the FDA oncology review teams have continued to expeditiously consider applications for new product approval. Between January 1, 2020 and November 1 2020, “15 new molecular entities and more than 80 efficacy supplements” were approved for the treatment of patients with cancer, according to Pazdur and Gao. A new dosing regimen of intravenous pembrolizumab that allows patients to receive the immunotherapy every 6 weeks instead of every 3 weeks, an injectable formulation of daratumumab and hyaluronidase-fijh that provides a subcutaneous route of administration, and a new indication for atezolizumab that makes administration possible through 3 different dosing regimens were among the approvals.
The FDA’s Office of Oncologic Disease (OOD) and OCE also conducted several outreach initiatives. For example, the OOD and OCE have hosted more than 10 listening sessions with patient advocacy groups and professional societies, during which the OOD, OCE, and group and society members discussed the most recent information on COVID-19-related guidance and answered participant questions.
“All aspects of cancer care have been affected by the COVID-19 pandemic, including cancer screening, treatment decisions, treatment options, as well as monitoring for progression or recurrence,” Pazdur and Gao wrote. “However, silver linings have begun to emerge, including a growing acceptance of decentralized trials, a better understanding of how trials can be made more patient-friendly to better serve the patient, and a greater appreciation of the potential role of real-world data in oncology product development.”
Gao JJ, Pazdur R. FDA Oncology Center of Excellence during COVID-19—working for patients with cancer. JAMA Oncol. Published online December 23, 2020. doi:10.1001/jamaoncol.20206783